Oral anticoagulant dabigatran recalled due to N-Nitrosodimethylamine impurity

Ascend Laboratories LLC. is voluntarily recalling certain lots of oral anticoagulant dabigatran etexilate capsules, USP 75 mg and 150 mg, due to the presence of a potentially carcinogenic nitrosamine, N-nitro-dabigatran, above acceptable levels. Product lots were distributed nationwide to U.S. wholesalers, distributors and retailers from June 2022 to October 2022. Patients who have received impacted lots of dabigatran are being advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.